Intravenous (IV) Pantoprazole in Erosive Esophagitis

NCT00133770

Last updated date
Study Location
Emory University School of Medicine
Atlanta, Georgia, 30322, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Esophagitis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Patients must be men or non-pregnant women (a documented negative pregnancy test at enrollment for females of child bearing age) at least 18 years of age

- Patients who present with a severe erosive esophagitis - confirmed by endoscopy (a baseline endoscopy within 24 hours of study enrollment) to be grade five or six, with or without stricture and/or ulcer

- Patients or their legally authorized representatives must be capable of understanding or giving signed and dated informed consent before the study

- Patients with a high probability for compliance and completion of the study

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- Patients with less than grade five esophagitis


- Patients with esophagitis other than reflux esophagitis, such as infectious
esophagitis and esophageal cancer


- Patients who present with gastrointestinal bleeding, hematocrit decrease greater than
6 units or require more than 2 units transfusion at the presentation or during the
time of the study


- Patients with severe comorbidities, such as liver diseases with asparate transaminase
(AST) or alanine transaminase (ALT) greater than 3 times upper limit normal (ULN);
alkaline phosphatase greater than 5 times the ULN; total bilirubin greater than 3.0
mg/dl; kidney diseases with serum creatinine greater than 2.0 mg/dl in men or 1.6
mg/dl in women; heart diseases; lung diseases; sepsis; and airway intubation.


- Patients with history of glaucoma in either eye; history of any intraocular eye
surgery within preceding 3 months; history of, or presence of, signs of optic nerve
swelling; history of acute change in vision; or vision loss in either eye.


- Patients with any malignancy (except skin cancer) which required therapy within the
last 6 months


- Patients with history of allergy to any proton-pump inhibitor (PPI) including
pantoprazole


- Patients with known human immunodeficiency virus infection


- Patients with organ transplantation


- Patients without the ability to comply with the study protocol and complete the study
in the judgment of the investigator


- Patients with prior administration of any PPI (within 72 hours) or histamine-2
receptor antagonist (within previous 24 hours) of study enrollment

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Advanced Information
Descriptive Information
Brief Title  ICMJE Intravenous (IV) Pantoprazole in Erosive Esophagitis
Official Title  ICMJE A Pilot Study of Efficacy and Safety of Continuous Intravenous Infusion of Pantoprazole in the Treatment of Severe Erosive Esophagitis
Brief Summary The aim of this study is to examine whether pantoprazole (Protonix) given through continuous intravenous infusion for 72 hours is superior to Protonix given through once a day IV injection in the treatment of erosive esophagitis.
Detailed Description

Gastroesophageal reflux disease (GERD) is a very common disease that affects 20-50% of adults in Western Countries. The disease can be divided into three clinical categories: nonerosive reflux disease (NERD), erosive reflux disease (ERD), and Barrett's esophagus.

Intravenous (IV) infusion produces a faster and steadier acid suppression than an oral regimen. Furthermore, some patients with severe erosive esophagitis cannot take pills by mouth and will benefit from an IV formulation. Recently, we observed healing of severe erosive esophagitis with continuous IV pantoprazole in several patients in 3 days. The safety of IV pantoprazole has been demonstrated in patients with GERD, with Zollinger-Ellison syndrome, or bleeding ulcer. This study is to define the safety and efficacy of continuous IV pantoprazole in the treatment of severe erosive esophagitis.

Comparison: The continuous IV pantoprazole compared to the once a day IV pantoprazole for 72 hours in the treatment of severe erosive esophagitis.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Esophagitis
Intervention  ICMJE Drug: pantoprazole
The continuous IV pantoprazole compared to the once a day IV pantoprazole for 72 hours in the treatment of severe erosive esophagitis
Other Name: Protonix
Study Arms  ICMJE Experimental: IV pantoprazole
The continuous IV pantoprazole compared to the once a day IV pantoprazole for 72 hours in the treatment of severe erosive esophagitis
Intervention: Drug: pantoprazole
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 29, 2013)
20
Original Enrollment  ICMJE
 (submitted: August 22, 2005)
18
Actual Study Completion Date  ICMJE March 2007
Actual Primary Completion Date July 2006   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients must be men or non-pregnant women (a documented negative pregnancy test at enrollment for females of child bearing age) at least 18 years of age
  • Patients who present with a severe erosive esophagitis - confirmed by endoscopy (a baseline endoscopy within 24 hours of study enrollment) to be grade five or six, with or without stricture and/or ulcer
  • Patients or their legally authorized representatives must be capable of understanding or giving signed and dated informed consent before the study
  • Patients with a high probability for compliance and completion of the study

Exclusion Criteria:

  • Patients with less than grade five esophagitis
  • Patients with esophagitis other than reflux esophagitis, such as infectious esophagitis and esophageal cancer
  • Patients who present with gastrointestinal bleeding, hematocrit decrease greater than 6 units or require more than 2 units transfusion at the presentation or during the time of the study
  • Patients with severe comorbidities, such as liver diseases with asparate transaminase (AST) or alanine transaminase (ALT) greater than 3 times upper limit normal (ULN); alkaline phosphatase greater than 5 times the ULN; total bilirubin greater than 3.0 mg/dl; kidney diseases with serum creatinine greater than 2.0 mg/dl in men or 1.6 mg/dl in women; heart diseases; lung diseases; sepsis; and airway intubation.
  • Patients with history of glaucoma in either eye; history of any intraocular eye surgery within preceding 3 months; history of, or presence of, signs of optic nerve swelling; history of acute change in vision; or vision loss in either eye.
  • Patients with any malignancy (except skin cancer) which required therapy within the last 6 months
  • Patients with history of allergy to any proton-pump inhibitor (PPI) including pantoprazole
  • Patients with known human immunodeficiency virus infection
  • Patients with organ transplantation
  • Patients without the ability to comply with the study protocol and complete the study in the judgment of the investigator
  • Patients with prior administration of any PPI (within 72 hours) or histamine-2 receptor antagonist (within previous 24 hours) of study enrollment
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00133770
Other Study ID Numbers  ICMJE 259-2004
3001K-200042 ( Other Grant/Funding Number: Wyeth )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dr. Qiang Cai MD/PhD, Emory University
Study Sponsor  ICMJE Emory University
Collaborators  ICMJE Wyeth is now a wholly owned subsidiary of Pfizer
Investigators  ICMJE
Principal Investigator:Qiang Cai, MD, PhDEmory University
PRS Account Emory University
Verification Date July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP